Single chamber, extravascular implantable cardioverterdefibrillator (ICD)

Notified Body #

Internal CECP dossier #

Date of reception of the dossier

Field of expert panel

Medical device type

Single chamber, extravascular implantable cardioverter defibrillator (ICD)

Intended purpose

The system is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients who are indicated for an ICD and who do not have symptomatic bradycardia.

Risk class / type

Screening step:
appropriate medical field
/ competence area

Novelty of device
and/or of related clinical procedure